Trial Outcomes & Findings for Phase II Study of Pembrolizumab and Nab-paclitaxel in HER-2 Negative Metastatic Breast Cancer (NCT NCT02752685)
NCT ID: NCT02752685
Last Updated: 2025-01-29
Results Overview
Overall response measured by RECIST version 1.1 and will be used in this study for assessment of tumor response. Complete response (CR) defined as disappearance of all target lesions; and partial response (PR) defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
Up to Year 2
Results posted on
2025-01-29
Participant Flow
Participant milestones
| Measure |
HR-Positive Participants
Participants with HR-positive metastatic breast cancer will receive nab-paclitaxel 100 mg/m2 on days 1 and 8 of the first 21-day treatment cycle. On the second 21-day treatment cycle, the participants will receive pembrolizumab 200 mg IV on the first day of the cycle, in addition to nab-paclitaxel 100 mg/m2 on days 1 and 8 of the cycle.
Pembrolizumab
Nab-Paclitaxel
|
cTNBC Participants
Participants with TNBC-positive metastatic breast cancer who in the chemotherapy run-in group (cNTBC) will receive nab-paclitaxel 100 mg/m2 on days 1 and 8 of the first 21-day cycle. On the second 21-day treatment cycle, the participants will receive pembrolizumab 200 mg IV on the first day of the cycle, in addition to nab-paclitaxel 100 mg/m2 on days 1 and 8 of the cycle.
Pembrolizumab
Nab-Paclitaxel
|
iTNBC Participants
Participants with TNBC-positive metastatic breast cancer in the immunotherapy run-in group (cNTBC) will receive pembrolizumab 200mg IV on day 1 of the first 21-day treatment cycle. nab-paclitaxel 100 mg/m2 on days 1 and 8 of the first 21-day cycle. On the second 21-day cycle, the participants will receive nab-paclitaxel 100 mg/m2 on days 1 and 8 of the cycle, in addition to pembrolizumab 200mg IV on day 1 of the cycle.
Pembrolizumab
Nab-Paclitaxel
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
30
|
20
|
|
Overall Study
COMPLETED
|
19
|
29
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Study of Pembrolizumab and Nab-paclitaxel in HER-2 Negative Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
HR-Positive Participants
n=20 Participants
Participants with HR-positive metastatic breast cancer will receive nab-paclitaxel 100 mg/m2 on days 1 and 8 of the first 21-day treatment cycle. On the second 21-day treatment cycle, the participants will receive pembrolizumab 200 mg IV on the first day of the cycle, in addition to nab-paclitaxel 100 mg/m2 on days 1 and 8 of the cycle.
Pembrolizumab
Nab-Paclitaxel
|
cTNBC Participants
n=30 Participants
Participants with TNBC-positive metastatic breast cancer who in the chemotherapy run-in group (cNTBC) will receive nab-paclitaxel 100 mg/m2 on days 1 and 8 of the first 21-day cycle. On the second 21-day treatment cycle, the participants will receive pembrolizumab 200 mg IV on the first day of the cycle, in addition to nab-paclitaxel 100 mg/m2 on days 1 and 8 of the cycle.
Pembrolizumab
Nab-Paclitaxel
|
iTNBC Participants
n=20 Participants
Participants with TNBC-positive metastatic breast cancer in the immunotherapy run-in group (cNTBC) will receive pembrolizumab 200mg IV on day 1 of the first 21-day treatment cycle. nab-paclitaxel 100 mg/m2 on days 1 and 8 of the first 21-day cycle. On the second 21-day cycle, the participants will receive nab-paclitaxel 100 mg/m2 on days 1 and 8 of the cycle, in addition to pembrolizumab 200mg IV on day 1 of the cycle.
Pembrolizumab
Nab-Paclitaxel
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56 years
n=5 Participants
|
53 years
n=7 Participants
|
55 years
n=5 Participants
|
55 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
30 participants
n=7 Participants
|
20 participants
n=5 Participants
|
70 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to Year 2Overall response measured by RECIST version 1.1 and will be used in this study for assessment of tumor response. Complete response (CR) defined as disappearance of all target lesions; and partial response (PR) defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
HR-Positive Participants
n=19 Participants
Participants with HR-positive metastatic breast cancer will receive nab-paclitaxel 100 mg/m2 on days 1 and 8 of the first 21-day treatment cycle. On the second 21-day treatment cycle, the participants will receive pembrolizumab 200 mg IV on the first day of the cycle, in addition to nab-paclitaxel 100 mg/m2 on days 1 and 8 of the cycle.
Pembrolizumab
Nab-Paclitaxel
|
cTNBC Participants
n=29 Participants
Participants with TNBC-positive metastatic breast cancer who in the chemotherapy run-in group (cNTBC) will receive nab-paclitaxel 100 mg/m2 on days 1 and 8 of the first 21-day cycle. On the second 21-day treatment cycle, the participants will receive pembrolizumab 200 mg IV on the first day of the cycle, in addition to nab-paclitaxel 100 mg/m2 on days 1 and 8 of the cycle.
Pembrolizumab
Nab-Paclitaxel
|
iTNBC Participants
n=19 Participants
Participants with TNBC-positive metastatic breast cancer in the immunotherapy run-in group (iNTBC) will receive pembrolizumab 200mg IV on day 1 of the first 21-day treatment cycle. nab-paclitaxel 100 mg/m2 on days 1 and 8 of the first 21-day cycle. On the second 21-day cycle, the participants will receive nab-paclitaxel 100 mg/m2 on days 1 and 8 of the cycle, in addition to pembrolizumab 200mg IV on day 1 of the cycle.
Pembrolizumab
Nab-Paclitaxel
|
|---|---|---|---|
|
Percentage of Participants With Best Overall Response Rate (BORR) of Complete Response or Partial Response
|
5 Participants
|
9 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Up to Year 2PFS defined as the time from initial treatment to documented disease progression or death.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Year 2OS defined as the time from initial treatment to death due to any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Year 2Percentage of patients whose disease shrinks or remains stable over a certain time period.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Year 2Defined as the time from onset of response to progression or death due to any reason, whichever occurs earlier.
Outcome measures
Outcome data not reported
Adverse Events
HR-Positive Participants
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
cTNBC Participants
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
iTNBC Participants
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
HR-Positive Participants
n=20 participants at risk
Participants with HR-positive metastatic breast cancer will receive nab-paclitaxel 100 mg/m2 on days 1 and 8 of the first 21-day treatment cycle. On the second 21-day treatment cycle, the participants will receive pembrolizumab 200 mg IV on the first day of the cycle, in addition to nab-paclitaxel 100 mg/m2 on days 1 and 8 of the cycle.
Pembrolizumab
Nab-Paclitaxel
|
cTNBC Participants
n=30 participants at risk
Participants with TNBC-positive metastatic breast cancer who in the chemotherapy run-in group (cNTBC) will receive nab-paclitaxel 100 mg/m2 on days 1 and 8 of the first 21-day cycle. On the second 21-day treatment cycle, the participants will receive pembrolizumab 200 mg IV on the first day of the cycle, in addition to nab-paclitaxel 100 mg/m2 on days 1 and 8 of the cycle.
Pembrolizumab
Nab-Paclitaxel
|
iTNBC Participants
n=20 participants at risk
Participants with TNBC-positive metastatic breast cancer in the immunotherapy run-in group (iNTBC) will receive pembrolizumab 200mg IV on day 1 of the first 21-day treatment cycle. nab-paclitaxel 100 mg/m2 on days 1 and 8 of the first 21-day cycle. On the second 21-day cycle, the participants will receive nab-paclitaxel 100 mg/m2 on days 1 and 8 of the cycle, in addition to pembrolizumab 200mg IV on day 1 of the cycle.
Pembrolizumab
Nab-Paclitaxel
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
4/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
20.0%
6/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Renal and urinary disorders
Acute kidney injury
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Endocrine disorders
Adrenal insufficiency
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Investigations
Alanine aminotransferase increased
|
40.0%
8/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
33.3%
10/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
50.0%
10/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Investigations
Alkaline phosphatase increased
|
25.0%
5/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
10.0%
3/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
55.0%
11/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Immune system disorders
Allergic reaction
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Immune system disorders
Alopecia
|
50.0%
10/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
33.3%
10/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
15.0%
3/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
10/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
33.3%
10/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
90.0%
18/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Metabolism and nutrition disorders
Anorexia
|
15.0%
3/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
20.0%
6/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
10.0%
2/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Psychiatric disorders
Anxiety
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
10.0%
3/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
15.0%
3/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
4/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
16.7%
5/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Gastrointestinal disorders
Ascites
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Investigations
Aspartate aminotransferase increased
|
40.0%
8/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
43.3%
13/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
65.0%
13/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
23.3%
7/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
20.0%
4/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Gastrointestinal disorders
Bloating
|
10.0%
2/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Investigations
Thrombocytopenia
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Investigations
Blood bilirubin increased
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
6.7%
2/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Eye disorders
Blurred vision
|
10.0%
2/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
10.0%
3/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
6.7%
2/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Reproductive system and breast disorders
Breast pain
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
10.0%
3/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
15.0%
3/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
General disorders
Chills
|
20.0%
4/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
6.7%
2/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Renal and urinary disorders
Chronic kidney disease
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Infections and infestations
Conjunctivitis
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Gastrointestinal disorders
Constipation
|
30.0%
6/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
26.7%
8/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
25.0%
5/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
45.0%
9/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
36.7%
11/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
30.0%
6/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Investigations
Creatinine increased
|
20.0%
4/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Psychiatric disorders
Delirium
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Psychiatric disorders
Depression
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
10.0%
3/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
10.0%
2/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
8/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
30.0%
9/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
35.0%
7/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Nervous system disorders
Dizziness
|
15.0%
3/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
10.0%
3/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
20.0%
4/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Eye disorders
Dry eye
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
10.0%
2/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Gastrointestinal disorders
Dry mouth
|
10.0%
2/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
6.7%
2/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
20.0%
4/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.0%
2/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
10.0%
2/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Nervous system disorders
Dysgeusia
|
15.0%
3/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
10.0%
2/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
2/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
5/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
36.7%
11/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
40.0%
8/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorder
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
General disorders
Edema limbs
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Endocrine disorders
Increased LDH
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
6.7%
2/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Gastrointestinal disorders
Esophageal pain
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Eye disorders
Eye Infection
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Eye disorders
Light Flash
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Eye disorders
Vision Change
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Injury, poisoning and procedural complications
Fall
|
10.0%
2/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
General disorders
Fatigue
|
40.0%
8/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
40.0%
12/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
45.0%
9/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
General disorders
Fever
|
30.0%
6/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
20.0%
6/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
10.0%
2/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
10.0%
2/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
6.7%
2/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Gastrointestinal disorders
Flatulence
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Respiratory, thoracic and mediastinal disorders
Flu like symptoms
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
13.3%
4/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
General disorders
Gait disturbance
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
10.0%
2/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
10.0%
3/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
20.0%
4/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Gastrointestinal disorders
Esophageal Spams
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Gastrointestinal disorders
Oral Swelling (Jaw/Gum)
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Gastrointestinal disorders
Early Satiety
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Gastrointestinal disorders
Stomatitis (Mouth Sores)
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Gastrointestinal disorders
Lip Mouth Sores Right Buccal, Tongue
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
General disorders
Biopsy Site Pain
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Nervous system disorders
Headache
|
25.0%
5/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
23.3%
7/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
30.0%
6/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Ear and labyrinth disorders
Hearing impaired
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Vascular disorders
Hot flashes
|
10.0%
2/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
6.7%
2/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Endocrine disorders
Hyperthyroidism
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
10.0%
2/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
35.0%
7/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
25.0%
5/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.0%
2/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
6.7%
2/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
25.0%
5/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
20.0%
4/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
10.0%
3/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
30.0%
6/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Metabolism and nutrition disorders
Hypotension
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Endocrine disorders
Hypothyroidism
|
20.0%
4/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
10.0%
3/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
10.0%
2/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Immune system disorders
Seasonal allergies
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
10.0%
3/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Infections and infestations
chest discomfort- upper respiratory infection
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Infections and infestations
Urinary tract infection
|
10.0%
2/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
16.7%
5/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Infections and infestations
Upper Respiratory Infection
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
10.0%
3/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Infections and infestations
Chest discomfort-UTI
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Infections and infestations
chest discomfort-Periocular/Orbital Rash Bilateral
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Infections and infestations
chest discomfort-viral gastroenteritis
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Infections and infestations
chest discomfort-Oral Thrush
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Psychiatric disorders
Insomnia
|
15.0%
3/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
16.7%
5/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
15.0%
3/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Reproductive system and breast disorders
Irregular menstruation
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Infections and infestations
Lip infection
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Vascular disorders
Localized edema
|
10.0%
2/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
10.0%
3/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
25.0%
5/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Vascular disorders
Lymphedema
|
10.0%
2/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
10.0%
3/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
10.0%
2/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Gastrointestinal disorders
Mucositis oral
|
10.0%
2/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
6.7%
2/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Musculoskeletal and connective tissue disorders
joint stiffness-left fingers
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Musculoskeletal and connective tissue disorders
Leg Cramps
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Musculoskeletal and connective tissue disorders
Aching Feet
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.0%
3/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
10.0%
3/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
6.7%
2/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
15.0%
3/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
20.0%
6/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
15.0%
3/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Gastrointestinal disorders
Nausea
|
60.0%
12/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
43.3%
13/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
65.0%
13/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
10.0%
2/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
6.7%
2/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Nervous system disorders
Aggitation
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Investigations
Neutrophil count decreased
|
15.0%
3/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
26.7%
8/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
20.0%
4/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Gastrointestinal disorders
Oral pain
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Gastrointestinal disorders
Pain
|
65.0%
13/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
40.0%
12/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
40.0%
8/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Cardiac disorders
Palpitations
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
16.7%
5/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Skin and subcutaneous tissue disorders
Papulopustular rash
|
10.0%
2/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Musculoskeletal and connective tissue disorders
Paresthesia
|
20.0%
4/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
20.0%
6/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Reproductive system and breast disorders
Pelvic pain
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Eye disorders
Periorbital edema
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
25.0%
5/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
20.0%
6/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
40.0%
8/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Investigations
Platelet count decreased
|
10.0%
2/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
10.0%
2/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural hemorrhage
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
10.0%
2/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
10.0%
2/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
10.0%
2/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
13.3%
4/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
10.0%
2/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
10.0%
3/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
5/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
20.0%
6/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
20.0%
4/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.0%
2/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
20.0%
6/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
30.0%
6/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Renal and urinary disorders
hesitancy
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Renal and urinary disorders
dysuria
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Skin and subcutaneous tissue disorders
Vaginal Irritation Desquamation
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Skin and subcutaneous tissue disorders
Scalp Folliculitis
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Skin and subcutaneous tissue disorders
Erythema (Mediport Site)
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
2/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Skin and subcutaneous tissue disorders
Contrast Initiated Right Hand Rash
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Skin and subcutaneous tissue disorders
Pruritic Rash - Upper Chest
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Skin and subcutaneous tissue disorders
Erythematous Patches AC + Popliteal Fossa
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Skin and subcutaneous tissue disorders
Left Foot Bottom Skin Peeling
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Skin and subcutaneous tissue disorders
Soft Tissue Lump (Left Flank)
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
10.0%
2/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
10.0%
3/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
20.0%
4/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
6.7%
2/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
15.0%
3/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Cardiac disorders
Supraventricular tachycardia
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Ear and labyrinth disorders
Tinnitus
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Infections and infestations
Upper respiratory infection
|
10.0%
2/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
10.0%
3/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Renal and urinary disorders
Urinary frequency
|
25.0%
5/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
25.0%
5/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Reproductive system and breast disorders
Vaginal dryness
|
10.0%
2/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
8/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
26.7%
8/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
20.0%
4/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Investigations
Weight gain
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Investigations
Weight loss
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
6.7%
2/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Investigations
White blood cell decreased
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
10.0%
2/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Infections and infestations
Wound infection
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Skin and subcutaneous tissue disorders
Dermatitis radiation
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
6.7%
2/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
General disorders
Edema face
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Endocrine disorders
decreased T4 Free
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Endocrine disorders
increased TSH
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Endocrine disorders
T3 Increased
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Endocrine disorders
T4 Increased
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Endocrine disorders
TSH decreased
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Eye disorders
decreased visual activity (when reading small print)
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Eye disorders
Right upper eye swelling
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Eye disorders
Eye pain
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Musculoskeletal and connective tissue disorders
Facial pain
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Eye disorders
Floaters
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Gastrointestinal disorders
blood on toilet tissue
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Gastrointestinal disorders
gas
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Gastrointestinal disorders
loose stool
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Gastrointestinal disorders
Ulcers
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Gastrointestinal disorders
Lower leg extremity edema
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Gastrointestinal disorders
left hand edema
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Eye disorders
Glaucoma
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
10.0%
2/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
6.7%
2/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
25.0%
5/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Vascular disorders
Hypertension
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
6.7%
2/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Infections and infestations
Influenza A
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Infections and infestations
Parotitis
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Infections and infestations
possible device related infection
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Infections and infestations
Rhinovirus
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Infections and infestations
sinus infection
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Injury, poisoning and procedural complications
Left Ankle Sprained
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
6.7%
2/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Infections and infestations
Lung infection
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
25.0%
5/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Musculoskeletal and connective tissue disorders
Baker's cyst L.popliteal fossa
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Musculoskeletal and connective tissue disorders
Baker's cyst right leg
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Musculoskeletal and connective tissue disorders
Feet Soreness
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Musculoskeletal and connective tissue disorders
Left Toes Cramping
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Musculoskeletal and connective tissue disorders
Right Toes Cramping (Curling)
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
6.7%
2/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Skin and subcutaneous tissue disorders
Nail infection
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
10.0%
3/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
15.0%
3/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Reproductive system and breast disorders
Right Breast Feeling Swollen
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Reproductive system and breast disorders
Spotting
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Skin and subcutaneous tissue disorders
Bilateral Redness of Feet
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Skin and subcutaneous tissue disorders
Chest induration
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis Right Heel
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Skin and subcutaneous tissue disorders
Ingrown Toe Nails
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Skin and subcutaneous tissue disorders
Left Breast Burning Sensation
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Skin and subcutaneous tissue disorders
Lesion on Right Chest
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Skin and subcutaneous tissue disorders
Lipoma
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Skin and subcutaneous tissue disorders
LLE erythema
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Skin and subcutaneous tissue disorders
Neck Rash - Left Trapezium
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Skin and subcutaneous tissue disorders
onycholysis loose nails
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Skin and subcutaneous tissue disorders
right breast/chest erythema (dermatitis)
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Skin and subcutaneous tissue disorders
Tinea Capitis
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Skin and subcutaneous tissue disorders
Verrusa Vulgaris
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
6.7%
2/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Nervous system disorders
Syncope
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
6.7%
2/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Nervous system disorders
Tremor
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Reproductive system and breast disorders
Vulval infection
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
3.3%
1/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Blood and lymphatic system disorders
Albumin
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Infections and infestations
Breast infection
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Investigations
Cardiac troponin I increased
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
10.0%
2/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Investigations
Cardiac troponin T increased
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Investigations
CD4 lymphocytes decreased
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Nervous system disorders
Confusion
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
10.0%
2/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Vascular disorders
DVT
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Nervous system disorders
Edema Cerebral Peritumoral
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Gastrointestinal disorders
Mouth Abrasions (Oral Mucosa)
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Cardiac disorders
Heart failure
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Vascular disorders
Hematoma
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
15.0%
3/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Metabolism and nutrition disorders
Folic Acid Deficiency
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Gastrointestinal disorders
Oral dysesthesia
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Musculoskeletal and connective tissue disorders
Pain- Lower Back
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Reproductive system and breast disorders
Pain Right Breast
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Reproductive system and breast disorders
Left Nipple Discharge
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Hypoxic Respiratory Failure
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Musculoskeletal and connective tissue disorders
Right neck pain
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Nervous system disorders
Seizure
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Infections and infestations
Sepsis
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Skin and subcutaneous tissue disorders
Left Breast scarring
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Skin and subcutaneous tissue disorders
Heat Rash Arms
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Skin and subcutaneous tissue disorders
Facial acne
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Skin and subcutaneous tissue disorders
Rash Right Nare
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Infections and infestations
skin infection
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Cardiac disorders
tachycardia
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
0.00%
0/30 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
5.0%
1/20 • 2 years
Systematic,- PI to monitor for AEs at every cycle visit. Note that Serious Adverse Event and All-Cause Mortality data are still being analyzed and will be provided once available.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place